UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055016 |
|---|---|
| Receipt number | R000062848 |
| Scientific Title | Role of aldosterone in various target organ damage in patients with hypertensive emergency: A cross-sectional study |
| Date of disclosure of the study information | 2024/07/19 |
| Last modified on | 2024/07/19 09:09:49 |
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Basic information
Public title
Relationship between organ damage and aldosterone concentration in hypertensive emergency
Acronym
Relationship between organ damage and aldosterone concentration in hypertensive emergency
Scientific Title
Role of aldosterone in various target organ damage in patients with hypertensive emergency: A cross-sectional study
Scientific Title:Acronym
Role of aldosterone in organ damage in patients with hypertensive emergency
Region
| Japan |
Condition
Condition
hypertensive emergency
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This cross-sectional study was conducted to characterize the association between RAS and the organ damage in patients with hypertensive emergencies.
Basic objectives2
Others
Basic objectives -Others
This cross-sectional study was conducted to characterize the association between RAS and the organ damage in patients with hypertensive emergencies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hypertensive target organ damage was evaluated on admission, including severe kidney impairment (eGFR less than 30 mL/min/1.73 m2, SKI), severe retinopathy, concentric left ventricular hypertrophy (c-LVH), thrombotic microangiopathy (TMA), heart failure with reduced ejection fraction (HFrEF) and cerebrovascular disease. Then, whether each organ injury was associated with blood pressure or a plasma aldosterone concentration was analyzed.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
During the period between April 2012 and August 2020, eighty-six patients visited the emergency department of Tokyo Bay Urayasu Ichikawa Medical Center, presenting with severe hypertension (systolicBP>180 mmHg and/or diastolic BP>120 mmHg) and the associated complications.
Key exclusion criteria
Among them, eighteen patients were transferred to other hospitals for further assessment and the treatment of severe hypertension. Of 68 patients admitted to our hospital, five patients died upon admission (i.e., before detailed evaluation); the causes of the death were brainstem hemorrhage (n=4) and aortic dissection (n=1). Ultimately, 63 patients were eligible for further evaluation.
Target sample size
63
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Suzuki |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology & Diabetes
Zip code
2790001
Address
Urayasu city todaijima 3-4-32, Chiba
TEL
0473513101
toshi-s@xj9.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Miyake |
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Division name
Department of Nephrology, Endocrinology & Diabetes
Zip code
2790001
Address
Urayasu city todaijima 3-4-32, Chiba
TEL
0473513101
Homepage URL
akihiro.miyake19@gmail.com
Sponsor or person
Institute
Toshihiko Suzuki
Department of Nephrology, Endocrinology & Diabetes
Tokyo Bay Urayasu Ichikawa Medical Center
3-4-32 Todaijima
Urayasu, Chiba 279-0001
Japan
Institute
Department
Personal name
Funding Source
Organization
none.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Bay Urayasu Ichikawa Medical Center
Address
Urayasu city todaijima 3-4-32, Chiba
Tel
0473513101
toshi-s@xj9.so-net.ne.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
63
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062848
